Parallel multicentre randomised trial of a clinical trial question prompt list in patients considering participation in phase 3 cancer treatment trials

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dc.contributor.authorTattersall, M.H.N.
dc.contributor.authorJefford, M.
dc.contributor.authorMartin, A.
dc.contributor.authorOlver, I.
dc.contributor.authorThompson, J.F.
dc.contributor.authorBrown, R.F.
dc.contributor.authorButow, P.N.
dc.date.issued2017
dc.descriptionAccepted 9 February 2017
dc.description.abstractObjective: To evaluate the effect of a clinical trial question prompt list in patients considering enrolment in cancer treatment trials. Setting: Tertiary cancer referral hospitals in three state capital cities in Australia. Participants: 88 patients with cancer attending three cancer centres in Australia, who were considering enrolment in phase 3 treatment trials, were invited to enrol in an unblinded randomised trial of provision of a clinical trial question prompt list (QPL) before consenting to enrol in the treatment trial. Interventions: We developed and pilot tested a targeted QPL for patients with cancer considering clinical trial participation (the clinical trial QPL). Consenting patients were randomised to receive the clinical trial QPL or not before further discussion with their oncologist and/or trial nurse about the treatment trial. Primary and secondary outcomes: Questionnaires were completed at baseline and within 3â €..weeks of deciding on treatment trial participation. Main outcome measure: scores on the Quality of Informed Consent questionnaire (QuIC). Results: 88 patients of 130 sought for the study were enrolled (43 males), and 45 received the clinical trial QPL. 49% of trials were chemotherapy interventions for patients with advanced disease, 35% and 16% were surgical adjuvant and radiation adjuvant trials respectively. 70 patients completed all relevant questionnaires. 28 of 43 patients in the control arm compared with 39 of 45 patients receiving the clinical trial QPL completed the QuIC (p=0.0124). There were no significant differences in the QuIC scores between the randomised groups (QuIC part A p=0.08 and QuIC part B p=0.92). There were no differences in patient satisfaction with decisions or in anxiety levels between the randomised groups. Conclusions: Use of a question prompt list did not significantly change the QuIC scores in this randomised trial. ANZCTR 12606000214538 prospectively registered 31/5/2006. Trial registration number: Results, ACTRN12606000214538.
dc.description.statementofresponsibilityMartin H N Tattersall, Michael Jefford, Andrew Martin, Ian Olver, John F Thompson, Richard F Brown, Phyllis N Butow
dc.identifier.citationBMJ Open, 2017; 7(3):1-7
dc.identifier.doi10.1136/bmjopen-2016-012666
dc.identifier.issn2044-6055
dc.identifier.issn2044-6055
dc.identifier.orcidOlver, I. [0000-0001-5478-1576]
dc.identifier.urihttp://hdl.handle.net/2440/105031
dc.language.isoen
dc.publisherBMJ Publishing Group
dc.rightsOpen Access This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work noncommercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http:// creativecommons.org/licenses/by-nc/4.0/
dc.source.urihttps://doi.org/10.1136/bmjopen-2016-012666
dc.subjectHumans
dc.subjectNeoplasms
dc.subjectBiomedical Research
dc.subjectInformed Consent
dc.subjectAged
dc.subjectMiddle Aged
dc.subjectPatient Participation
dc.subjectPatient Satisfaction
dc.subjectAustralia
dc.subjectFemale
dc.subjectMale
dc.subjectClinical Trials, Phase III as Topic
dc.subjectTertiary Care Centers
dc.subjectSurveys and Questionnaires
dc.titleParallel multicentre randomised trial of a clinical trial question prompt list in patients considering participation in phase 3 cancer treatment trials
dc.typeJournal article
pubs.publication-statusPublished

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